Using a vagal stimulator to reduce the need for nasogastric tubes after surgery
The Role of a Vagal Stimulator to Reduce the Frequency and Duration on Nasogastric Tube Following Abdominal Surgery
This study is testing if a vagal nerve stimulator can help adults recover from surgery faster and reduce the need for uncomfortable feeding tubes.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Pittsburgh Academic / other |
| Locations | 1 site (Pittsburgh, Pennsylvania) |
| Trial ID | NCT06648759 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the use of a vagal nerve stimulator to alleviate postoperative ileus (POI) in adults undergoing major abdominal surgeries. POI is a common complication that can lead to the need for nasogastric tube placement, which can cause discomfort and prolong hospital stays. The study aims to determine if non-invasive vagal stimulation can facilitate the resolution of POI, thereby reducing the reliance on nasogastric tubes. Participants will be randomly assigned to receive either the vagal nerve stimulator or a placebo to assess the effectiveness of the intervention.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older who are undergoing laparoscopic or open colorectal surgery and are expected to develop postoperative ileus.
Not a fit: Patients who are pregnant, unable to communicate in English, or have cognitive impairments may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the need for nasogastric tubes, minimizing patient discomfort and shortening hospital stays.
How similar studies have performed: While the use of vagal nerve stimulation is a novel approach in this context, anecdotal evidence suggests it may successfully reduce the need for nasogastric tubes in similar situations.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults (18 and older) undergoing laparoscopic or open colorectal surgery, or any major abdominal surgeries at UPMC Shadyside * Development of post-operative ileus * Anticipation of a nasogastric (ng) tube being placed Exclusion Criteria: * Pregnant subjects * Subjects who are unable to read, write, or speak English fluently * Subjects who have a developmental or neurological disorder and are not cognitively able to provide consent
Where this trial is running
Pittsburgh, Pennsylvania
- UPMC Shadyside Hospital — Pittsburgh, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Jacques E Chelly, MD, PhD, MBA — University of Pittsburgh, UPMC
- Study coordinator: Carly Riedmann, MPH
- Email: riedmannca@upmc.edu
- Phone: 412-623-4147
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.